1. Clinical Laboratory Improvement Amendments of 1988 ( CLIA ’ 88 )
Federal regulations which govern test results that are used to assess a patient’s condition or make a clinical decision about the patient
CLIA’ 88 classifies tests depending upon complexity as: high, moderate, provider-performed microscopy, or waived
A CLIA Certificate of Waiver is required for labs performing only waived testing

2. Waived Tests
Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under CLIA criteria. CLIA requires that waived tests must be simple and have a low risk for erroneous results. This does not mean that waived tests are completely error-proof. They should be performed correctly

3. Testing Oversight
CLIA does not specify requirements for directors of laboratories with a Certificate of Waiver ( some states require a physician )
The person whose name appears on the CLIA Certificate as the Medical Director is responsible for testing oversight and decision making .

4. Medical Director or Designee Responsibilities
Ensure appropriate preparation prior to testing, i.e. patient ID, collection and handling
Identify staff responsible for performing and supervising testing.
Ensure staff are trained in each test they perform, aspects of safety, and QC prior to reporting test results
Ensure periodic evaluation of competency
Especially important since no specific degree or certification is required and turnover rates are high

5. Medical Director or Designee
Responsibilities:
Establish written policies and procedures for waived testing
Make decisions on how the test results are used and when follow up testing is required
Approve policies before a test is put in place
Review and approve policies every 3 years or more often if changes are made

6. Importance of Getting it Right!
Consider this:
Waived tests are used to adjust medication doses, i.e. anticoagulant therapy
Pregnancy test prior to undergoing radiology tests
Glucose monitoring in diabetic patients

7. Importance of Preanalytical Processes
Preanalytical errors are the main cause of laboratory errors
Why?
Human factor
Difficult to detect and correct

8. Focus on Prevention!
Standardize processes & understand variables, i.e.:
Two patient identifiers
Use dedicated staff for collection
Correct order of draw
Methods to prevent hemolysis

9. Two Patient Identifiers
Two patient identifiers are used when collecting blood or other samples for clinical testing
Two patient identifiers are used when providing other treatments or procedures
The patient’s physical location is not used as an identifier    
Containers used for blood and other specimens are labeled in the presence of the patient
Ref: Joint Commission, camlab,2007

10. Methods to prevent hemolysis
Appropriate needle bore
Remove the tourniquet as soon as possible
Allow alcohol to dry
Avoid vigorous mixing or shaking
Avoid prolonged contact of serum or plasma
with cells

11. Staff Training and Periodic Competencies
Staff identified by name or job description
Staff trained for each test they are authorized to perform including performance of quality control
Staff trained on the use of each instrument operation, calibration and maintenance

12. Waived Policy Highlights
Waivered laboratory procedures (as defined by the Clinical Laboratory Improvement Amendment of 1988) may be performed by certified personnel with the guidance and assistance of the Medical Director of the lab or designee or may be performed by RMAs, CMAs, Certified Phlebotomists who have been authorized to perform the tests

13. Procedure Authorization Staff Member Signature/Date ___________________ Trainer Signature/Date_________________________
Test /Instrument
Test/Instrument
Glucose Meter ( Accu-Chek )
General Operation
Test Performance
Quality Control
Maintenance
Troubleshooting
PT/INR ( Coaguchek )
General Operation
Test Performance
Quality Control
Maintenance
Troubleshooting

14. Assessing Competencies
Competency assessed using at least two of
the following:
Direct observation of testing/or submit a blind specimen
Review of result reporting, track errors
Review of maintenance and QC logs
Use of a written exam
Competency should be assessed at least
at orientation and annually thereafter

15. Components of Policies and Procedures for Waived Testing
Confirmatory testing and result follow-up
Specimen type, collection, ID, and labeling
Specimen preservation
Instrument maintenance and function checks ( calibration )
Storage of reagents

16. Components, continued:
Reagent use, expiration dates
Quality control frequency and type ( including corrective action when unacceptable )
Test performance
Reporting results ( do not report if quality control is unacceptable )
Equipment validation

17. Waived Policy Highlights
PROCEDURES:
A Bedside Glucose Accu-Chek Advantage
PURPOSE: This policy establishes guidelines for the performance of accurate bedside glucose testing used in clinical decision making such as the rapid evaluation of patients with suspected hypo-or hyperglycemia, the determination of appropriate insulin doses or infusion rates, and assessing the effectiveness of treatment regimens. This method is not used for the diagnosis of diabetes mellitus. These guidelines follow recommendations defined by certain regulatory agencies as dictated by principles of good laboratory practice.

18. Waived Policy Highlights
Negative Result: Only one (1) pink colored line appears in the control region. No apparent pink colored line is visible in the test region. A negative result indicated that there is no Strep A antigen in the swab sample or the Strep A antigen concentration is below the detection level. A negative result should be cultured to confirm the absence of Strep A infection.

19. Waived Policy Highlights/Result Follow up
Critical Values and Unusual Results:
Any glucose value <40 mg/dL or >400 mg/dL should be repeated. Repeat results exceeding these limits are designated as Critical Values and should be reported as soon as practical to the physician or physician extender
If at any time results of bedside glucose testing, regardless of whether they are critical values, are inconsistent with the patient’s status, notify the physician or physician extender for instructions.

20. Quality Control
Quality Control checks are performed at the frequency and number of levels recommended by the manufacturer
If the manufacturer doesn’t recommend the frequency and number, the medical director, designee or organization must define

21. Documentation of Quality Control
Controls may be documented on a quality control log or located in the patient’s clinical record
Often internal quality controls are documented in the patient’s clinical record, while external is documented on a log along with reagent lot #s, open dates and expiration dates

22. Waived Policy Highlights
Quality Control:
Accu-Chek Comfort Curve glucose controls, low and high levels
are used for quality control as follows:
Frequency: Run both levels of controls (low and high) with the
first run of the day. Also, both levels of controls should be run:
Each time a new vial of test strips is opened.
When a vial of test strips has been left opened.
If the Advantage Meter has been dropped.
Whenever the patient’s result contradicts the patient’s condition.
When batteries are replaced.

23. Waived Policy Highlights
Validation of Controls:
Log control results along with other required information on the Quality Control Log. If control test results are not within expected limits, the following steps are recommended:
Confirm that the HemoCue Microcuvettes are within the expiration date shown on the label.
Retest with new controls.
Log the invalid control results and the repeat results
on the Quality Control Log along with the corrective action used.
Special Note: If these steps do not correct the problem, call Northern Hospital Laboratory for assistance or contact HemoCue Technical Services by calling
DO NOT REPORT PATIENT TEST RESULTS!

24. Instrument Maintenance/Calibration
Follow manufacturer’s instructions for instrument maintenance and calibration checks
Instrument maintenance and calibration checks must be documented
Very important! Individual test results can be associated with quality control, reagent lots, instrument records, and calibration checks

25. Preventive Maintenance Schedule
C. HemoCue 201+-Hemoglobin System
1. Daily a. Remove the cuvette holder from the photometer. Clean the cuvette holder with 70% alcohol or mild soap solution. Completely dry the cuvette holder before replacing in the photometer. Wipe the surfaces with a commercially pre moistened disinfecting cloth ( must be EPA registered disinfectant ) SQUEEZING OFF THE EXCESS SOLUTION.
2. Monthly a. Monthly inspection of workstation by designee.
3. Annually a. Have NHSC Biomedical Engineering check for proper electrical grounding.
REFERENCE: 1. HemoCue 201+ Blood Hemoglobin Operating Manual

26. Result Reporting
Quantitative test result reports in the patient’s clinical record for waived testing are accompanied by reference limits ( normal values ) specific to the test method used and the population served
Reference: Joint Commission Standards for Waived Testing

27. Hard Copy or EMR
Result on a hard copy: Design the lab result form with reference limits adjacent to the test result
Result in EMR: EMR page for entering lab results may not be formatted to have reference limits adjacent to the test result
If not what? The reference limits must be located elsewhere in the medical record and the result must have a notation directing the reader to that location

28. Documentation of Critical Values
Very Important to document reporting of critical values, i. e.,
Critical value reported to Dr. John Smith at 2:30 pm on April 15, 2012 by Mary Midkiff

29. Morbidity and Mortality Weekly Report Indicates Risks
Lack of current manufacturers’ instructions including updates
Failure to follow manufacturers’ instructions including performing quality control
Reporting of incorrect results
Lack of adherence to expiration dates
Inappropriate storage requirements
Reference: Morbidity and Mortality Weekly report, November 11, 2005

30. Morbidity and Mortality , conti.,
Failure to perform test system function checks or calibration checks
Lack of documentation, including quality control and tests performed
Inadequate training
Lack of understanding about good laboratory practices
Reference: Morbidity and Mortality Weekly Report, November 11,2005